NDC Code(s) : 58602-765-76
Packager : Aurohealth LLC

Category : HUMAN OTC DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Childrens Pain ReliefAcetaminophen TABLET, CHEWABLE
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:58602-765
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACETAMINOPHEN(UNII: 362O9ITL9D)
(ACETAMINOPHEN - UNII:362O9ITL9D) 		ACETAMINOPHEN160 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS CITRIC ACID(UNII: XF417D3PSL)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
COPOVIDONE K25-31(UNII: D9C330MD8B)
CROSPOVIDONE (120 .MU.M)(UNII: 68401960MK)
D&C RED NO. 27(UNII: 2LRS185U6K)
D&C RED NO. 30(UNII: 2S42T2808B)
DEXTROSE MONOHYDRATE(UNII: LX22YL083G)
ETHYLCELLULOSE (4 MPA.S)(UNII: KC5472WRJK)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MANNITOL(UNII: 3OWL53L36A)
SODIUM STARCH GLYCOLATE TYPE A POTATO(UNII: 5856J3G2A2)
STEARIC ACID(UNII: 4ELV7Z65AP)
SUCRALOSE(UNII: 96K6UQ3ZD4)
Product Characteristics
Color purple Score 2 pieces
Shape ROUND Size 16 mm
Flavor GRAPE Imprint Code J26
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:58602-765-764 in 1 CARTON 13/09/2017
16 in 1 BLISTER PACK Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC Monograph Drug M013 09/13/2017

LABELER - Aurohealth LLC(078728447)

Establishment
Name Address ID/FEI Business Operations
APL HEALTHCARE LIMITED 650844777 manufacture(58602-765)

PRINCIPAL DISPLAY PANEL

AUROHEALTH
NDC 58602-765-76
Ages 2-11
Children's Pain Relief
Acetaminophen 160 mg
Pain reliever/Fever reducer
 

  • Aspirin Free                         
  • Ibuprofen Free

 
Grape Flavor

Compare to the active ingredient in
Children's Tylenol® Chewables*
24
Chewable Tablets

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 160 mg (24 Chewable Tablets)